Study Stopped
Stopping criterion met (N. adjudicated EP1)
Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease
B3
1 other identifier
interventional
1,390
9 countries
54
Brief Summary
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with pacemaker or ICD indication who require dual-chamber pacing due to sinus node disease (SND), with or without atrioventricular (AV) block.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 16, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJanuary 18, 2024
January 1, 2024
7.5 years
October 16, 2015
January 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
First event of Sustained Paroxysmal AF or Persistent AF or stroke or TIA, whichever comes first.
three years
Secondary Outcomes (6)
Sustained Paroxysmal AF (SPAF)
Three years
Persistent AF
Three years
Permanent AF
Three years
Stroke/TIA
Three years
Worsening Heart failure Hospitalization (wHF-H)
Three years
- +1 more secondary outcomes
Study Arms (2)
Active group - CLS ON
EXPERIMENTALDevice will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON; Intervention: DDD+CLS
Control group - CLS OFF
ACTIVE COMPARATORDevice will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF
Interventions
Eligibility Criteria
You may qualify if:
- Patients with Class I or II recommendations for permanent pacing due to SND, with or without AV block according to the current guidelines;
- Patients for whom dual-chamber pacing is indicated or preferred;
- Patients with an optimized and stable antiarrhythmic medical therapy at the time of enrolment;
- Closed Loop Stimulation function was not previously activated;
- No stroke events from implant;
- Patient implanted for the first time;
You may not qualify if:
- Permanent AF (PermAF)
- NYHA Class IV Heart Failure
- Stage V kidney dysfunction
- Any indication to Cardiac Resynchronization Therapy (CRT)
- Life expectancy \< 1
- Minors
- Pregnant or breast-feeding patients
- Participation in another interventional trial
- Atrial fibrillation ablation (left pulmonary veins) or other cardiac surgery \< 3 m
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Wuhan Asia Heart Hospital
Wuhan, Jinghan District, 430022, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Nangang District, China
Xuanwu Hospital Capital Medical University
Beijing, West City District, 100053, China
Semmelweis University Heart and Vascular Center
Budapest, 1122, Hungary
Max Super Speciality Hospital
New Delhi, 110017, India
Ospedali Riuniti di Ancona
Torrette, Ancona, 60126, Italy
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, Bari, 70021, Italy
Ospedale "Bolognini"
Seriate, Bergamo, Italy
Presidio Ospedaliero Ospedale Sant'Anna
San Fermo della Battaglia, Como, 22020, Italy
Ospedale Civile SS. Annunziata
Savigliano, Cuneo, 12038, Italy
Ospedale di Rho
Rho, Italia, 20017, Italy
Ospedale F. Ferrari
Casarano, Lecce, Italy
Ospedale Maria SS Addolorata
Eboli, Salerno, 84025, Italy
Ospedale Santa Maria della Stella
Orvieto, Terni, 05018, Italy
Ospedale di Conegliano
Conegliano, Treviso, 31015, Italy
Azienda Ospedaliera Policlinico Consorziale
Bari, Italy
Ospedale Antonio Cardarelli
Campobasso, 86100, Italy
Azienda Ospedaliera di Caserta Sant'Anna e San Sebastiano
Caserta, Italy
A.O.U. Policlinico Vittorio Emanuele
Catania, Italy
Ospedale Santa Maria Nuova
Florence, 50122, Italy
Ospedale Fabrizio Spaziani
Frosinone, Italy
ASST Valle Olona - Ospedale Sant'Antonio Abate
Gallarate, Italy
ASST RHODENSE - Ospedale Guido Salvini
Garbagnate, Italy
Ospedale Ferdinando Veneziale
Isernia, 86170, Italy
Ospedale Vito Fazzi
Lecce, 73100, Italy
Nuovo Ospedale delle Apuane
Massa, 54100, Italy
Ospedale V. Monaldi
Napoli, 80131, Italy
A.O.P. Federico II
Napoli, Italy
A.O.U Maggiore della Carità di Novara
Novara, 28100, Italy
Azienda Ospedaliera di Padova
Padua, Italy
Ospedale S. Maria della Misericordia
Perugia, Italy
Nuovo Ospedale Santo Stefano
Prato, 59100, Italy
Ospedale "Maria Paternò Arezzo"
Ragusa, 97100, Italy
Ospedale Infermi di Rimini
Rimini, 47923, Italy
Policlinico Umberto I
Roma, 00161, Italy
Policlinico Casilino
Roma, 00169, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Italy
Azienda Ospedaliera "S. Maria" di Terni
Terni, 05100, Italy
Ospedale di Treviso
Treviso, 31100, Italy
Hospital Serdang
Kajang, 43000, Malaysia
National Heart Center Singapore
Singapore, 169609, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Sejong General Hospital
Bucheon-si, 14154, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Seul National University Bundang Hospital
Gyeonggi-do, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seul National University Hospital
Seoul, 03080, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Related Publications (9)
Puglisi A, Altamura G, Capestro F, Castaldi B, Critelli G, Favale S, Pavia L, Pettinati G. Impact of Closed-Loop Stimulation, overdrive pacing, DDDR pacing mode on atrial tachyarrhythmia burden in Brady-Tachy Syndrome. A randomized study. Eur Heart J. 2003 Nov;24(21):1952-61. doi: 10.1016/j.ehj.2003.08.011.
PMID: 14585254RESULTPuglisi A, Favale S, Scipione P, Melissano D, Pavia L, Ascani F, Elia M, Scaccia A, Sagone A, Castaldi B, Musacchio E, Botto GL; Burden II Study Group. Overdrive versus conventional or closed-loop rate modulation pacing in the prevention of atrial tachyarrhythmias in Brady-Tachy syndrome: on behalf of the Burden II Study Group. Pacing Clin Electrophysiol. 2008 Nov;31(11):1443-55. doi: 10.1111/j.1540-8159.2008.01208.x.
PMID: 18950302RESULTHealey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.
PMID: 22236222RESULTRusso V, Rago A, Papa AA, Golino P, Calabro R, Russo MG, Nigro G. The effect of dual-chamber closed-loop stimulation on syncope recurrence in healthy patients with tilt-induced vasovagal cardioinhibitory syncope: a prospective, randomised, single-blind, crossover study. Heart. 2013 Nov;99(21):1609-13. doi: 10.1136/heartjnl-2013-303878. Epub 2013 May 30.
PMID: 23723446RESULTde Cock CC, Giudici MC, Twisk JW. Comparison of the haemodynamic effects of right ventricular outflow-tract pacing with right ventricular apex pacing: a quantitative review. Europace. 2003 Jul;5(3):275-8. doi: 10.1016/s1099-5129(03)00031-x.
PMID: 12842643RESULTLieberman R, Grenz D, Mond HG, Gammage MD. Selective site pacing: defining and reaching the selected site. Pacing Clin Electrophysiol. 2004 Jun;27(6 Pt 2):883-6. doi: 10.1111/j.1540-8159.2004.00551.x.
PMID: 15189520RESULTLamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. doi: 10.1056/NEJMoa013040.
PMID: 12063369RESULTConnolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. 2000 May 11;342(19):1385-91. doi: 10.1056/NEJM200005113421902.
PMID: 10805823RESULTToff WD, Camm AJ, Skehan JD; United Kingdom Pacing and Cardiovascular Events Trial Investigators. Single-chamber versus dual-chamber pacing for high-grade atrioventricular block. N Engl J Med. 2005 Jul 14;353(2):145-55. doi: 10.1056/NEJMoa042283.
PMID: 16014884RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2015
First Posted
October 20, 2015
Study Start
September 1, 2015
Primary Completion
March 1, 2023
Study Completion
December 1, 2023
Last Updated
January 18, 2024
Record last verified: 2024-01